Recovering Hearts. Saving Lives.
ABIOMED TCT INVESTOR BREAKFAST: 2016COMMITTED TO IMPROVING OUTCOMES IN PROTECTED PCI AND CARDIOGENIC SHOCK
Recovering Hearts. Saving Lives.
LEGAL DISCLAIMERSThis presentation contains forward-looking statements, including statements regarding development of Abiomed's existing and new products, the Company's progress
toward commercial growth, and future opportunities, the Company’s guidance for future financial performance and expected regulatory approvals. Each forward-looking
statement contained in this presentation is subject to risks and uncertainties that could cause actual results to differ materially from those projected in such statement,
including uncertainties associated with development, testing and related regulatory approvals; the potential for future losses; the impact of complex manufacturing
processes and high quality requirements; dependence on limited sources of supply; competition; technological change; government regulation; third-party reimbursement
to the Company’s customers; litigation matters; future capital needs and uncertainty of additional financing, and other risks and challenges detailed in the Company's
filings with the Securities and Exchange Commission, including the most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Readers are
cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this presentation. The Company undertakes no obligation to
publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this
presentation or to reflect the occurrence of unanticipated events, whether as a result of new information, future events or otherwise, unless otherwise required by law.
2
U.S. Food and Drug Administration Approvals
● The Impella 2.5™ System is a temporary (≤ 6 hours) ventricular support device indicated for use during high risk percutaneous coronary interventions (PCI)
performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart
team, including a cardiac surgeon, has determined high risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 System in these patients may
prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary
occlusions and may reduce peri- and post-procedural adverse events.
●The Impella2.5™, Impella CP®, Impella 5.0™, and Impella LD™ Catheters, in conjunction with the Automated Impella Controller (collectively, "Impella® System
Therapy"), are temporary ventricular support devices intended for short term use (≤ 4 days for the Impella 2.5 and Impella CP, and ≤ 6 days for the Impella 5.0,
and Impella LD) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (< 48 hours) following acute myocardial infarction or open
heart surgery as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures (including
volume loading and use of pressors and inotropes, with or without IABP). The intent of the Impella System Therapy is to reduce ventricular work and to provide
the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.
●The Impella RP® is indicated for providing circulatory assistance for up to 14 days in pediatric or adult patients with a body surface area ≥ 1.5 m2 who develop
acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.
For safety information associated with Abiomed’s technologies, visit www.protectedpci.com/hcp/information/isi and www.cardiodenicshock.com/hcp/information/isi.
Impella ECPTM, Impella CP® Next Generation, Impella 5.5TM, Impella BTRTM, The Impella PediatricTM, and Symphony® are in
development and are not approved for use or sale.
The ABIOMED logo, ABIOMED, Impella CP, Impella RP and Symphony are registered trademarks of Abiomed, Inc. in the U.S.A. and certain foreign
countries. Impella 2.5, Impella 5.0, Impella LD, Impella BTR, Impella cVAD, Impella ECP and Recovering hearts. Saving lives. is a trademark of Abiomed, Inc.
Recovering Hearts. Saving Lives.
INFORMATION INTENDED SOLELY FOR INVESTORS3
FOR INVESTORS ONLY
The content of this presentation includes a discussion of Abiomed products
that have not been approved or cleared by the United States Food and Drug
Administration and are not available for sale in the United States. This
presentation also discusses certain uncleared and unapproved uses of
Abiomed products.
This information is intended solely for purposes of informing the investment
community, and not for any other purposes. This information is intended For
Investors Only, and not for customers, potential customers or other
Healthcare Professionals.
Recovering Hearts. Saving Lives.
TCT 2016 TAKEAWAYS:4
1. Existing Opportunity: “The Field of Heart Recovery”
Protected PCI Program: 6% Penetration of 121k potential U.S. patients
AMI Cardiogenic Shock: 6% Penetration of 100k potential U.S. patients
2. Mid-Term Opportunity:
Japan: 2nd largest med tech market ; Potential 50k patients
STEMI: Pilot Study FDA Approved. Goal to revolutionize AMI care (heart attack) ; 250k
potential U.S. patients
3. Long-Term Opportunity:
New products (fiber optic sensor, remote monitoring, Impella ECP, Impella 5.5, Impella BTR)
New geographies (ROW)
Recovering Hearts. Saving Lives.
COMMITTED TO IMPROVING OUTCOMES IN PROTECTED PCI AND CARDIOGENIC SHOCK
DR. SETH BILAZARIAN, ABIOMED CHIEF MEDICAL OFFICER
ABIOMED TCT INVESTOR BREAKFAST: 2016
Recovering Hearts. Saving Lives.
DR. SETH BILAZARIAN, CHIEF MEDICAL OFFICER, 2015 6
• 23 years in practice as Interventional Cardiologist, privileges at
Massachusetts General, Lahey Clinic, Lawrence General
• Served on the faculty as an instructor at Harvard Medical School,1995 - 2015
• Founded largest community based clinical cardiology research program in
Partners Healthcare, with 50 RCT FDA trials/studies
• FDA physician advisor and cardiac device panel member, 2008 - 2015
• Board certified in cardiovascular medicine, nuclear cardiology, vascular
ultrasound, interventional cardiology, vascular and endovascular medicine
• Blog on cardiology : “Practitioner’s Corner” established in 2009, on
theheart.org and Medscape
• Cardiosource World News: Top 10 Cardiologists Most Followed by
Cardiologists, #6, 2015
• Bachelor of Science in Engineering in Chemical Engineering from Tufts
University
• MD from University of Massachusetts Medical School, internship and
residency at Johns Hopkins Hospital, and cardiology/interventional cardiology
fellowship at Boston University Hospital
Recovering Hearts. Saving Lives.
NEW HIGH RISK PCI INDICATION APPROVED BY FDA
MARCH 23, 2015Impella 2.5
7
FOR INVESTORS ONLY
Recovering Hearts. Saving Lives.
UPDATED 2015 & 2016 HIGH RISK PCI CONSENSUSACC/SCAI/HFSA/STS EXPERT CONSENSUS, ACC INTERVENTIONAL SCIENTIFIC COUNCIL
FOR INVESTORS ONLY
8
Recovering Hearts. Saving Lives.
ISCHEMIC HEART DISEASE PUBLICATIONS
“ an evolution of contemporary interventional cardiology is
necessary to treat the increasingly higher-risk patients with
whom we are confronted.”
Revascularization is Superior: “In a cohort of patients with
ischemic cardiomyopathy, the rates of death from any or
cardiovascular causes, and death or hospitalization for
cardiovascular causes were significantly lower over 10 years
among patients who underwent CABG than among those who
received medical therapy alone.”
Kirtane et al, Circulation 2016
Velazquez et al, New England Journal of Medicine 2016
“The majority of patients hospitalized for new-onset HF did
not receive testing for ischemic CAD either during
hospitalization or within 90 days, …suggests significant
underutilization of ischemic CAD assessment.”
Doshi et al, Journal of the American College of Cardiology 2016
FOR INVESTORS ONLY
9
Recovering Hearts. Saving Lives.
CHESS VS. SPEED CHESS
During PCI..
• Unplanned events occur with
equipment or patient behavior
• The response of hearts with poor
cardiac reserve can force “in and
out” placement of stents and not
complete revascularization
• Hemodynamic support helps
avoid early termination, especially
for patients who are surgical
turndowns
Navin Kapur, MD TCT 2015FOR INVESTORS ONLY
10
Recovering Hearts. Saving Lives.
PROTECTED PCI AWARENESS: PATIENT IDENTIFICATION11
TCTMD Panel Discussion Clinical Dossier
Referral Outreach ProgramMobile Learning Lab
ProtectedPCI.com
Key Partners
FOR INVESTORS ONLY
Recovering Hearts. Saving Lives.
AMI CARDIOGENIC SHOCK FDA PMA APPROVAL
13
CARDIOGENIC SHOCK INDICATION APPROVED BY FDA
APRIL 7, 2016
The intent of the Impella system therapy is to reduce ventricular work and to provide the
circulatory support necessary to allow heart recovery and early assessment of residual myocardial
function.
The Impella heart pumps stabilize the patient's hemodynamics, unload the left ventricle, perfuse
the end organs and allow for recovery of the native heart.
Impella® is the only
percutaneous heart pump
proven safe and effective for
hemodynamic stabilization to
enable Heart Recovery
FOR INVESTORS ONLY
14
Progressive
Myocardial Dysfunction
End Organ
Failure
REVERSE THE CARDIOGENIC SHOCK SPIRAL
Impella Now FDA Approved for Cardiogenic Shock Therapy
Ischemia
End Organ Perfusion
Myocardial
Recovery
Patients
Reverse Spiral
Cardiac Output
MAP
Death Spiral of
Cardiogenic Shock
Cardiac Power Output
Cardiogenic Shock Identifiers
• SBP <90 mmHg or on
Inotropes/Pressors
• Cold, clammy, tachycardia
• Lactate elevated >2 mmoI/L
Cardiogenic etiology evaluation
• EKG (STEMI / NSTEMI)
• Echocardiography
• PA catheter, Cardiac Output, CPO,
CI, PCWP, SvO2
FOR INVESTORS ONLY
15
INCIDENCE OF CARDIOGENIC SHOCK GROWING
STEMI Cardiogenic Shock in
Medicare Age Increasing2
Cardiogenic Shock in
STEMI Increasing1
Nationwide Inpatient Sample Databases
2010 2014
36,969
56,508
53%
Age 65 only, excludes non-Medicare population
1. Kolte D, et al. J Am Heart Assoc. 2014;3(1):e000590.
2. Centers for Medicare and Medicaid database, MEDPAR FY14.FOR INVESTORS ONLY
16
LIMITATIONS OF CONVENTIONAL THERAPY
1- Samuels LE et al , J Card Surg. 1999
2- Thiele H et al. NEJM 2012 - Clinicaltrial.gov # NCT00491036
IABP-SHOCK II
Randomized Controlled Trial2N = 600
Mortality Risk with
Inotropes/Vasopressors1
N = 40
IABP (n=301)
Medical Therapy (n=299)41.3%
39.7%
FOR INVESTORS ONLY
17
SHORT-TERM MCS LINKED TO REDUCED MORTALITY & REDUCED COSTS
Stretch et al. JACC 2014
“IABP use and in-hospital death were associated with
cost increases of 25.2%.” … “Predictors of death
included a diagnosis of cardiogenic shock and use of
IABP or cardiopulmonary resuscitation before short-term
MCS.”
O’Neill, et al., J. Int. Cardiol, 2014
1.0
0.8
0.6
0.4
0.2
0 5 10 15 20 25 30
Su
rviv
al
Rate
IABP/Inotropes Pre-
PCI
Impella® Pre-PCI
Days from Initiation of Impella
Log-Rank, P=0.004
30-Day Survival
cVAD Registry™*
N=154
FOR INVESTORS ONLY
“ 2007 to 2011 use of pVADs increased 1,511% with a
mortality decrease from 41% to 33%. Hospital costs also
declined.”
18
ABIOMED IMPELLA QUALITY (IQ) PROGRAM:
IMPROVING OUTCOMES IN PROTECTED PCI AND CARDIOGENIC SHOCK
19
ABIOMED IQ PROGRAM MISSION
+ =
Data
Analytics
Best
Practices
Standard
ProtocolsCase-Based
Learning
Goal
IQ Database
cVAD Registry
FDA Study Data
Identify insights
with a goal to
improve
outcomes
Algorithms & Order
Sets based on Best
Practices and
Appropriate Use
24/7 clinical
support
After Action
Reviews
Improved Survival
with Native Heart
Recovery
Improve real-world outcomes in Protected PCI and AMI Cardiogenic Shock patients through training,
education and utilization of clinical guidelines, protocols and best practices derived from observational
quality assurance data (IQ), IRB approved registry (cVAD) and IDE approved FDA studies
FOR INVESTORS ONLY
20
88% Recovery
91% Recovery
93% Recovery
0% to 33% 34% to 66% 67% to 100%
Impella Sites(282 sites supported >4 AMI/CGS patients)
Survival to
Explant
ABIOMED IQ DATABASE , AMI/CGS APRIL 2016 – OCT 2016
n=205 n=1142 n=644
SURVIVAL WITH HEART RECOVERY IN AMI SHOCK (FY’17)
N=1,991 patients
April 2016 to Oct 2016
1st Tercile 2nd Tercile 3rd Tercile
% Heart Recovery
% Bridge to next therapy
59% Average Survival
FOR INVESTORS ONLY
21
0% 50% 100%
50%
100%
NATIVE HEART RECOVERY BEST OPTION FOR PATIENT AND
PAYERS… IMPROVES QUALITY OF LIFE, LOWERS COST
Survival*
Native
Heart
Recovery
Impella1
Lowest Survival Tercile
88% Recovery1
2Middle Survival Tercile
91% Recovery2
3
Highest Survival Tercile
93% Recovery3
ECMOECMO Meta-analysis ‡
‡ Cheng et al. Annals of Thoracic Surgery, 2014 (meta-analysis of 20 studies, 1820 patients)
ECMO for AMI/CGS patient population is off-label per FDA indications
LVAD
Durable LVAD †
Intermacs 1 & 2
† Intermacs 1 and 2, Intermacs Registry, 2015
*Survival w/o heart recovery
requires implantable LVAD /
heart transplant
FOR INVESTORS ONLY
22
FIVE OBSERVATIONS THAT APPEAR TO CORRELATE WITH
IMPROVED OUTCOMES IN AMI CARDIOGENIC SHOCK
Use of Invasive Hemodynamic Monitoring (PA catheter)1
Timing of support (use of unloading with Impella® prior to PCI)2,3
Minimizing exposure to toxic inotropic medications4,5
Involvement of Abiomed team and support1
Protocol-driven support, weaning and escalation6,7
1. Data on file. Abiomed IQ Database, AMI/CGS April 2015-March
2016. Danvers, MA: Abiomed.
2. Data on file. USpella Registry Data. Danvers, MA: Abiomed
3. O'Neill WW, et al. Circulation. 2012;126(14):1717-1727.
4. Samuels LE, et al. J Card Surg. 1999;14(4):288-293.
5. De Backer D, et al. 2008.
6. Kormos RL, et al. 2006.
7. Korabathina R, et al. Catheter Cardiovasc Interv.
2012;80(4):593-600.
FOR INVESTORS ONLY
23
Escalate (and
Ambulate) or
Transfer
IMPELLA® BEST PRACTICES IN AMI CARDIOGENIC SHOCK
Identify(Protocols)
• SBP <90 mmHg or on Inotropes/Pressors
• Cold, clammy, tachycardia
• Lactate elevated >2 mmoI/L
Stabilize
Early • Impella Support pre-PCI
• Reduce Inotropes/Pressors
Complete
Revascularization
• PCI Guidelines based
in Cardiogenic Shock
Assess for Myocardial Recovery(Weaning and Transfer Protocols)
• ↑Cardiac Output
• ↑Cardiac Power Output
• ↑ Urine Output
• ↓ Lactate
• ↓ Inotropes
Myocardial
Recovery
No Recovery
• EKG (STEMI / NSTEMI)
• Echocardiography
• If available, PA catheter,
Cardiac Output, CPO, CI,
PCWP, SvO2
• Ongoing Left heart failure
• Assess for Right heart failure
Cardiogenic etiology evaluation
Metric #1Hemodynamic
Monitoring
Metric #2Stabilize Early with
Impellawith Complete
Revascularization
Metric #3Reduce Toxic
Inotropes
Metric #4Protocol-Driven
Wean or Escalate
Metric #5ABMD Support
FOR INVESTORS ONLY
24
8,500 patients
today
FDA Approval
April 2015
ABIOMED IQ PROGRAM FOR PROTECTED PCI
Protected PCI Patients in IQ Database Since FDA Approval
Micropuncture Access technique
Abiomed Support for initial case
Scheduling Cases allows advanced
Abiomed clinical support
Complete Revascularization
reduces post PCI adverse events
Post PCI support for severe LV
dysfunction or prolonged PCI
5 Observations that appear to correlate
with Improved Outcomes in Protected PCI
Quality Assurance Case Surveillance
Procedural Survival 99.5%
Bleeding related complications 0.9%
FOR INVESTORS ONLY
25
TCT 2016 TAKEAWAYS:
1. Existing Opportunity: “The Field of Heart Recovery”
Protected PCI Program: 6% Penetration of 121k potential U.S. patients
AMI Cardiogenic Shock Partnership: 6% Penetration of 100k potential U.S. patients
2. Mid-Term Opportunity:
Japan: 2nd largest med tech market ; Potential 50k patients
STEMI: Pilot Study FDA Approved. Goal to revolutionize AMI care (heart attack) ; 250k
potential U.S. patients
3. Long-Term Opportunity:
New products (fiber optic sensor, remote monitoring, Impella ECP, Impella 5.5, Impella BTR)
New geographies (ROW)
FOR INVESTORS ONLY
Recovering Hearts. Saving Lives.
New England Journal of Medicine: 2003; 348:2007-18
Infarct = dead heart muscle
26
A GROWING HEART FAILURE POPULATION… WHY?
American Heart Association 2015 Statistics:
47% of women and 36% of men will die within 5yrs of first myocardial infarction
FOR INVESTORS ONLY
Recovering Hearts. Saving Lives.
Door-to-Balloon Mortality decreasing
with Heart Failure increasing
Ezekowitz JA et al JACC 2009
STEMI POPULATION IMPACTING HEART FAILURE
Assuming future FDA approvals for use of Impella in additional indications
10%
76% 39%
14%
Large Infarcts Lead to Remodeling
and Development of Heart Failure
FOR INVESTORS ONLY
227
28
• FDA approval of feasibility study to evaluate
Impella CP® use patients with ST segment
elevation myocardial infarction (STEMI),
without cardiogenic shock
• Hypothesis: Unloading may have impact on
infarct size related to reperfusion injury in
STEMI patients
• 50 patients at up to 10 sites, 2 arms. Initial
Impella support and randomized to immediate
PCI vs. 30min unloading prior to PCI
• Expected to initiate in the first half of calendar
2017 and complete within 18 months
• STEMI patient represents a potential new
patient indication (200k / year) that may benefit
from Impella unloading the left ventricle
STEMI FEASIBILITY STUDY APPROVED
FOR INVESTORS ONLY
Recovering Hearts. Saving Lives.
CONCLUSION: ABIOMED IS COMMITTED TO IMPROVING
OUTCOMES IN PROTECTED PCI AND CARDIOGENIC SHOCK
• Protected PCI addresses an unmet need for an undertreated population
• Cardiogenic Shock caries one of the highest mortality rates in the
hospital and heart recovery remains the best option
• Abiomed’s IQ Program allows for collaboration with hospitals on
training, education and protocol development designed to improve
outcomes for Protected PCI and cardiogenic shock
• Unloading therapy may represent a revolutionary approach to reduce
the number of future heart failure patients after STEMI
FOR INVESTORS ONLY
29
30
TCT 2016 TAKEAWAYS:
1. Existing Opportunity: “The Field of Heart Recovery”
Protected PCI Program: 6% Penetration of 121k potential U.S. patients
AMI Cardiogenic Shock Partnership: 6% Penetration of 100k potential U.S. patients
2. Mid-Term Opportunity:
Japan: 2nd largest med tech market ; Potential 50k patients
STEMI: Pilot Study FDA Approved. Goal to revolutionize AMI care (heart attack) ; 250k
potential U.S. patients
3. Long-Term Opportunity:
New products (fiber optic sensor, remote monitoring, Impella ECP, Impella 5.5, Impella BTR)
New geographies (ROW)
Recovering Hearts. Saving Lives.
DR. THORSTEN SIESS, ABIOMED CHIEF TECHNOLOGY OFFICER
NEW INDICATION & PIPELINE UPDATE
ABIOMED TCT INVESTOR BREAKFAST: 2016
Recovering Hearts. Saving Lives.
ABIOMED: THORSTEN SIESS, PHD
Dr. Thorsten Siess joined Abiomed in 2005 upon its acquisition of Impella
CardioSystems, AG, which he co-founded in 1998 and has served as Manager of R&D,
then Chief Technology Officer. His work in the development and marketing of the Impella
2.5 and 5.0 in Europe led to their CE Mark approval. During his time at the University of
Aachen he developed the Impella technology which served as a platform for the entire
Impella product portfolio. The products, which allow early intervention through a pencil-
sized VAD, are now available in 70 centers in 11 countries. Prior to founding Impella, Dr.
Siess served as Scientist in the Biomedical Technology Team at Helmholtz-Institute of
Biomedicine at the University of Aachen in Germany. Dr. Siess received a Ph.D. degree
as well as his MASc in Mechanical Engineering from the Technical University of Aachen.Dr. Thorsten SiessChief Technology Officer
The Abiomed research team (~35 people), lead by Dr. Siess, has deep rooted knowledge in the field of
cardiovascular research and a track-record of innovation. The company and / or team invented or co-
invented: Hemopump, the artificial heart, iTET, diagonal pumps, Deltastream, the first pulsatile extracorporeal
pump for ECMO, a-Med, Impella, Circulite, Symphony, expandable pump technologies (ECP), and patented
the first implantable centrifugal pumps.
FOR INVESTORS ONLY – DISCUSSION OF DEVICES IN DEVELOPMENT
32
Recovering Hearts. Saving Lives.
IMPROVEMENTS IN EASE OF USE AND SUPPORT
• Quick console set-up time
• Higher flow percutaneous pump
• Impella RP (right-side support device)
• Axillary Implant / Ambulation for Patients
• Optical Sensor
• Simulator training tools and support
• Remote link services and 24x7 support line
FOR INVESTORS ONLY
33
Recovering Hearts. Saving Lives.
34
15 “cannula” patents (expiring 2017 to
2031)
6 pending applications
4 “pigtail” patents (expiring 2023 to 2031)
2 pending application
5 “guidewire” patent (expiring 2031)
3 pending applications
31 “motor” patents (expiring 2017 to
2028)
14 pending applications
14 pressure sensor patents (expiring
2017 to 2021)
13 pending applications
30 “pump design” patents (expiring 2017
to 2035)
6 pending applications
Other Impella patents
22 patents (expiring 2017 to 2033)
7 pending applications
ECP IP Portfolio (Acquisition 2014):
67 patents (expiring 2019 to 2035)
119 pending applications
Abiomed Patent Summary Worldwide
254 total patents
188 Impella, 66 non-Impella, (expiring
2016-2035)
220 pending applications
170 Impella, 50 non-Impella
INTELLECTUAL PROPERTY: 254 PATENTS, 220 PENDING
FOR INVESTORS ONLY – DISCUSSION OF DEVICES IN DEVELOPMENT
Recovering Hearts. Saving Lives.
• Quicker set-up
• Improved placement and accuracy
• Advanced real-time patient management and
weaning protocols
SMART PUMPING: INTEGRATED OPTICAL PRESSURE SENSOR
Optical
Sensor
Placement
Signal
FOR INVESTORS ONLY – DISCUSSION OF DEVICES IN DEVELOPMENT
35
Recovering Hearts. Saving Lives.
IMPELLA® ECP: EXPANDABLE CARDIAC POWER
• Smallest percutaneous heart pump:
~9F pump / catheter. Expands to ~20F
• Designed for flow >3.5 liters per minute
• Simple insertion / explant: Advances into
left ventricle over pigtail
• Smooth clear polyurethane membrane
sits across the aortic valve
• Ideal for Protected PCI indication
• First in Man planned CY 2H 2017
FOR INVESTORS ONLY – DISCUSSION OF DEVICES IN DEVELOPMENT
Inflow
Outflow
36
Recovering Hearts. Saving Lives.
IMPELLA® ECP: INSERTION
FOR INVESTORS ONLY – DISCUSSION OF DEVICES IN DEVELOPMENT
337
Recovering Hearts. Saving Lives.
CHRONIC CARE
BRIDGE TO HEART RECOVERY AND/OR HEART REMODELING
Recovering Hearts. Saving Lives.
LIMITATIONS OF CURRENT HEART FAILURE (LVADS)
IMPLANTABLE DEVICES
• Surgical sternotomy procedures
• Long hospitalizations, high costs, and
frequent readmissions
• LVADs core the myocardium for implantation.
Not designed for heart recovery and makes
heart transplants more difficult
• Risk profile too high for Class III patients
(stroke, bleeding, infection, etc.)
• Limited heart transplant availability
ICU
FOR INVESTORS ONLY – DISCUSSION OF DEVICES IN DEVELOPMENT
39
Recovering Hearts. Saving Lives.
A NEW APPROACH TO IMPLANTATION AND AMBULATION
Axillary Insertion of the Impella (5.0):
• Minimally Invasive ; No Sternotomy
• 90% of Impella 5.0 procedures are
currently completed via axillary
insertion (>2,000 patients)
• Maximum duration of support, to date:
107 days with Impella 5.0*
* Product labeling allows for the clinical decision to leave Impella 2.5, Impella CP, Impella 5.0 and Impella LD in place beyond the intended duration of four to six days due to unforeseen circumstances.
FOR INVESTORS ONLY – DISCUSSION OF DEVICES IN DEVELOPMENT
40
Recovering Hearts. Saving Lives.
ABIOMED’S DESIGN FOR IMPELLA 5.0 / 5.5 / BTR:
DESIGNED FOR RECOVERY OR REMODELING
Designed to significantly improve
patient hemodynamics
Simple insertion via axillary
(no sternotomy/thoracotomy)
Simple device design, lower cost
Improves patient QOL and
allows for ambulation
Promotes native heart recovery
or remodeling
FOR INVESTORS ONLY – DISCUSSION OF DEVICES IN DEVELOPMENT
41
Recovering Hearts. Saving Lives.
42
PATIENT MOBILIZATION: HELPS OUTCOMES & QUALITY OF LIFE
Video of Impella 5.0 German Patient with Axillary Insertion:
FOR INVESTORS ONLY – DISCUSSION OF DEVICES IN DEVELOPMENT
Recovering Hearts. Saving Lives.
THE IMPELLA® 5.5: NEXT GENERATION IMPELLA® 5.0
Optical Sensor &
Cable
Monolithic motor housing
Rear sleeve bearing
with soldering PCBfront sleeve and
axial thrust
bearing
• ~9F catheter / ~19F pump
• Estimated Flow: 5.5 Liters / Minute
• Designed for duration of weeks – months
• Percutaneous / axillary / transcaval
insertion and explant
• First in man estimated: CY 2H 2017
• Requires PMA
FOR INVESTORS ONLY – DISCUSSION OF DEVICES IN DEVELOPMENT
43
Recovering Hearts. Saving Lives.
IMPELLA® 5.5 CADAVER AXILLARY IMPLANT
FOR INVESTORS ONLY – DISCUSSION OF DEVICES IN DEVELOPMENT
44
Recovering Hearts. Saving Lives.
IMPELLA® BTR: “BRIDGE TO RECOVERY”
• No sternotomy required, axillary insertion/implant
• Designed as longer term (up to 1 year) with
discharge wearable driver
• Size Design: ~9F catheter and ~19F pump
• Estimated flow ≥ 5.5 Liters / Minute
• Stage: Feasibility in Animals without anticoagulation
• Requires PMA
Wearable Driver
FOR INVESTORS ONLY – DISCUSSION OF DEVICES IN DEVELOPMENT
45
Recovering Hearts. Saving Lives.
CONCLUSION: THE ENGINEERING OF HEART RECOVERY
• Abiomed invented percutaneous heart pumps and has strong IP
• Abiomed continues to improve Ease-of-Use in cath lab and ICU
• Smart pumping and smaller, higher flow pumps will impact heart
recovery outcomes
• Chronic heart failure patients (Class III) need less invasive, axillary
implant and higher flow to remodel the left ventricle
FOR INVESTORS ONLY
46
Recovering Hearts. Saving Lives.
CLOSING REMARKS
MICHAEL R. MINOGUE, ABIOMED CHIEF EXECUTIVE OFFICER, PRESIDENT & CHAIRMAN
ABIOMED TCT INVESTOR BREAKFAST: 2016
Recovering Hearts. Saving Lives.
ELECTRICITY
PERCUTANEOUS, PMA-APPROVED TECHNOLOGIES
Stents/PCI2 Pacemaker / ICDs Edwards TAVR Impella®
CY 2015 Units/Patients per
year in U.S.1> 1 Million ~400,000 ~19,000 ~10,000
1. ACC/AHA 2015 Heart Disease and Stroke Statistics—2015 Update & Respective company websites and Leerink and William Blair analyst models
2. Percutaneous Coronary Intervention.
PUMPPLUMBING VALVE
48
FOR INVESTORS ONLY
Recovering Hearts. Saving Lives.
49
IMPELLA® HEART PUMP: A BREAKTHROUGH TECHNOLOGY
• FDA Approvals: “Safe & Effective” for
High Risk PCI and Cardiogenic Shock;
HDE Impella RP®* for 5 Impella pumps
• CMS: DRG 215 Implant ; 268 ICU/Explant
• 1,100 U.S. hospitals ; 45,000+ patients
• 7 Clinical Guidelines ; >380 publications
• CE Mark (2002) ; Japanese PMDA (2016)
• 254 patents & 220 patents pending
FOR INVESTORS ONLY
* High Risk PCI PMA Approval for Impella 2.5; Cardiogenic Shock PMA Approval for Impella, 2.5, CP, 5.0, LD ; HDE for Impella RP
Recovering Hearts. Saving Lives.
Reduces Mortality*:
• “Use of short-term MCS in
the United States has
increased rapidly, whereas
rates of in-hospital mortality
have decreased” 6
• “Hemodynamic support
demonstrates significantly
reduced mortality with
PVADs when compared to
IABP in patients undergoing
PCI”18
IMPELLA® HEART PUMPS ALIGN WITH HEALTHCARE REFORM
1. O’Neill et al, Circulation. PROTECT II, 2012
2. Maini et al, Journal of American College of Cardiology (abstract). USPella, 2013
3. Burzotta et al J Card Med, 2008
4. Dixon et al. Journal of American College of Cardiology Interv. PROTECT I, 2009
5. Sjauw et al. Journal of American College of Cardiology. MACH 2, 2009
6. Stretch et al, Journal of the American College of Cardiology, 2014
7. Lemaire et al, Annals of Thoracic Surgery, 2013
8. O’Neill et al, Journal of American College of Cardiology. USPella, 2013
9. Maini et al,Journal of Catheterization and Cardiovascular Interventions, 2014
10. Maini et al, Expert Review Pharmaeconomics & Outcomes Research, 2014
11. Roos et al, Journal of Medical Economics, 2013
12. Gregory et al, American Health & Drug Benefits Journal, 2013
13. Gregory et al, Journal of Managed Care Medicine, 2013
14. Krenn et al, SCAI, 2014
15. Aryana et al, Heart Rhythm Society, 2014
16. Wohns et al. International Society for Minimally Invasive Cardiothoracic Surgery, 2014
17. Lamarche et al. Journal of Thoracic and Cardiovascular Surgery, 2010
18. Patel et al. Journal of Interventional Cardiology, 2015
50
Improves Quality of Life:
• Reduction of Class III and
IV Heart Failure: 58%1,
52%2
• Improves Quality of Life:
Heart ejection fraction
increase of 32%3, 31%4,
22%1, 17%2, 13%5
Is Cost-Effective:
• “Declining hospital costs”
(Cost Reduction $45k and $54k
per case in AMI and CAD) 6
• Reduces hospital length of stay 8,9,11,12,13,14,15,16,17
• Reduces expensive hospital
readmission costs11
• Creates minimal impact on
payer’s budget 12
FOR INVESTORS ONLY
Recovering Hearts. Saving Lives.
ABIOMED AND U.S. HOSPITAL NETWORK COLLABORATING TO
IMPROVE EDUCATION, TRAINING AND CLINICAL OUTCOMES
Specialized
Protected PCI &
Heart Recovery
Hospital
Community
Hospital
Community
Hospital
Community
Hospital
• 400+ Specialized Protected PCI &
Heart Recovery Hospitals
• 1,100 of 1,400 Heart Hospitals* and
Cath Lab Hospitals trained to Implant
Impella for Cardiogenic Shock
• CMS DRG: 215 (implant) / 268 (ICU
care & explant)
• Dedicated resources at hospital to
advance patient care with Abiomed IQ
Program (>250 Abiomed field team
members ; 24x7 Call Center)
* 95% penetrated in heart hospitals (cath labs / surgical suites) ; 55% in cath lab only hospitals
Protocol:
FOR INVESTORS ONLY
51
Recovering Hearts. Saving Lives.
FY’16
1. GAAP net income for fiscal year 2015 was $113.7 million included an income tax benefit of the $86.5million. This was a result of the Q4’FY15 release of the valuation allowance of most deferred tax assets. The release of the
valuation allowance was a onetime accounting adjustment with the offset recorded on the balance sheet as short and long term deferred tax assets based on the Company's estimates of sustainable profitability.
2. Cash, cash equivalents, short and long term marketable securities
GAAP Operating Income ($M)1 Debt: $0
Deferred Tax Asset1: $45 Million
($25)
$2
($11)
$8
$17
FY’12 FY’11 FY’13 FY’14
$60$77
$88
$118
$146
Cash ($M)2
POSITIVE CASH FLOW & STRONG BALANCE SHEET
$29
52
FY’10
FY’12
FY’11
FY’13 FY’14 FY’15
FY’15
$213
FY’16
$66
$237
Q2’17
FOR INVESTORS ONLY
Recovering Hearts. Saving Lives.
Japan
Impella
5.0TM
Impella
CP®
53
Future
Protected PCITM
Impella ECPTM
Today / 2016
Products
Indications
Geographies
Cardiogenic
Shock
Impella
RP® HDE
Rest of World
STEMI
(Infarct
Reduction)
Impella 5.5TM
* Impella® ECP, Impella® 5.5, Impella® BTR, are in development and are not approved for use or sale
Germany
Right-Side &
Left Side
Support
Additional
Indications
(2017/2018)
U.S.
IMPELLA® PLATFORM: A LONG RUN-WAY FOR GROWTH
Heart Failure
(Class III)
Impella
2.5TM
250K U.S.
Patients100K U.S.
Patients
50K Patients20K Patients221K Patients
Impella BTRTM
Wearable
Driver
FOR INVESTORS ONLY
Recovering Hearts. Saving Lives.
PIPELINE PRODUCT DEMO
Recovering Hearts. Saving Lives.
THANK YOU